Category Archives: Quality

25Jan/17
wakup call

Rapid Regulatory Changes Will Impact Medical Devices and Diagnostics Industry

By: Hugo Felix, Director Design Quality Assurance, Bard Access Systems

This is Your Wake Up Call!

The Medical Device and Diagnostics Industry is experiencing rapid regulatory changes.  To deal with these changes there are certain key areas that need to be addressed so we can thrive, rather than just survive.  Quality Systems need to account for that, deal with the rapid pace and help us manage it.

New standards, regulations and guidances will have a significant impact in our industry:

  • The International Organization for Standardization (ISO) published ISO 13485:2016.  This represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices
  • ISO 13485:2016 has a 3 year transition period and no new accreditations to the 2003 version after year 2
  • TC210 just approved changes to ISO 14971, Application of Risk Management to Medical Devices and an update to the accompanying ISO TR 24971 and a new TR for Post Market Surveillance

For its part, the US FDA issued guidances late last year on Benefit Risk Analysis for Pre and Post Market and draft guidances for deciding when to submit a 510K for device changes and another for software changes. MDD/IVDD to MDR/IVDR change is slated for May 2017 with full implementation deadlines of 2020 for MDR and 2022 for IVDR.

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04Jan/17
quality

Is Your Quality Unit Ready to Submit Quality Metrics Data Across Your Supply Chain?

By: Sandra K. Rodriguez, Market Analyst

FDA “Encourages” Industry to Volunteer for e-Inspections Program

Based on Quality Metrics, FDA’s e-Inspections program is encouraging industry to implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing.    In response to stakeholder feedback, the agency issued a revised draft guidance document in November 2016 titled “Submission of Quality Metrics Data[1].”

The draft guidance explains how the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) intend to utilize submitted data and quality metrics to help ensure that their policies and practices continue to support continuous improvement and innovation in the pharmaceutical manufacturing industry.  For more background on the evolution of this initiative see ISPE, FDA and the Metrics Future and FDA to Grade Industry on a Curve – Are You Ready?
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11Oct/16
closed-loop-process-with-copyright-wp5

Does Having a Closed Loop Process Really Matter to Your Business?

New White Paper: The Future of Change and Configuration Management in the Med-Tech Industry

Recalls are on the rise. How can you avoid them?

Analysis shows a 97% increase in the annual number of medical device recalls for the 10-year period, increasing from 604 recalls in FY 2003 to 1,190 recalls in FY 2012. 

Want to learn how a Closed Loop Process can prevent recalls, drive accelerated innovation, improve product quality and enhance company performance?  Does Having a Closed Loop Process Really Matter?

Download the white paper to find out how Med-Tech Innovators are avoiding recalls by implementing closed loop change and configuration management processes.

Contact: research@axendia.com to see if you qualify for a complimentary access code and save $499.
27Sep/16
man-jumping-over-the-ledge-wp4

Don’t Solve Quality Problems, Avoid Them

New White Paper: The Future of Change and Configuration Management in the Med-Tech Industry

Can you distribute poor quality products while complying with all applicable regulatory requirements? Sure! After all, you can conduct a recall of poor quality products in compliance with all applicable regulations.  FDA’s Top Medical Device official agrees.

Jeff Shuren, M.D., J.D., Director of FDA’s Center for Devices and Radiological Health (CDRH), put it this way: “…one device manufacturer can meet FDA requirements and still make a poor quality device; whereas, a second manufacturer may not comply with all FDA requirements and yet make a high-quality device.”

Is your organization focused on Solving Quality Problems or Avoiding Them?  Download the white paper to find out how Med-Tech Innovators have been able to shift their focus on improving market presence, manufacturing processes and product quality.

Contact: research@axendia.com to see if you qualify for a complimentary access code and save $499.
21Sep/16
Data Integrity in LS

Data Integrity – A Requirement for FDA Compliance, Quality and Beyond

On Demand Webinar Announced

Data integrity and quality are foundational for regulatory compliance and good science, an issue that was recently highlighted by the new “FDA Guidance for Data Integrity and Compliance with cGMP”. This guidance was issued to address a growing number of data integrity violations and underscores the importance of data quality and integrity to support intellectual property protection and patient filings in regulated and non-regulated spaces.

DownloadData Integrity in Life Sciences a PDF of this inforgraphic.

We discuss what Goldilocks and Life-Sciences companies have in common during the webinar. An on demand recording is available here.